Senior CDISC Programmer & Data Standards Lead

Cytel; Indianapolis (IN); On-site; USD 140,000 - 200,000; Full time

Job summary

Cytel is seeking a Principal Programmer CDISC SME to work embedded with a global pharmaceutical client. You will provide subject matter leadership on CDISC standards across SDTM, ADaM, and related submission deliverables, ensuring accuracy, traceability and regulatory readiness.

You will collaborate with statisticians, programmers and data management to design data structures, produce compliant datasets, and mentor teams while driving process improvements and governance across the programming

Qualifications

• Degree in Computer Science, Mathematics or Statistics with 7+ years of statistical programming experience.
• Extensive hands-on CDISC standards experience across SDTM, ADaM, CDASH and define.xml.
• Expert review of CDISC datasets and submission packages for regulatory readiness.
• Experience guiding study setup, data standards and dataset design with cross-functional teams.
• Strong leadership, communication and organizational skills.
• Ability to lead vendor and cross-site programming efforts with stakeholders.

Responsibilities

• Provide CDISC SME leadership for SDTM, ADaM, CDASH and submission deliverables.
• Review datasets, annotated CRFs, define.xml and submission packages for accuracy.
• Advise study teams on data standards, dataset design and submission readiness.
• Collaborate with statisticians and programming colleagues on data structures for reports and analyses.
• Lead or contribute to production, validation and oversight of programming deliverables.
• Contribute to CDISC governance, standards documentation and training materials.
• Mentor colleagues and present CDISC best practices across teams.
• Identify gaps and drive process improvements to increase efficiency and quality.

Skills

CDISC standards

Statistical programming

Leadership

Cross-functional collaboration

Communication skills

Regulatory submission readiness

Quality assurance

Mentorship and training

Education

BSc/MSc/Diploma in Computer Science, Mathematics/Statistics

Job description

Cytel is seeking a Principal Programmer CDISC SME to work embedded with a global pharmaceutical client. You will provide subject matter leadership on CDISC standards across SDTM, ADaM, and related submission deliverables, ensuring accuracy, traceability and regulatory readiness.

You will collaborate with statisticians, programmers and data management to design data structures, produce compliant datasets, and mentor teams while driving process improvements and governance across the programming